Safety and Effectiveness Study of the Mi-thos4 Transcatheter Mitral Valve Replacement System for Patients 65 and Older with Severe Mitral Valve Regurgitation at High Surgical Risk

What this Trial Is About

The trial investigates the safety and performance of the Mi-thos4 Mitral Heart Valve together with the Mi-thos4 Transcatheter Delivery System in patients with severe mitral valve disease who are at high surgical risk. This prospective, single-arm, multicenter clinical study aims to assess how well this device works and its safety profile in this patient group. Participants receive the Mi-thos4 valve replacement via a transcatheter delivery system using a transapical approach. The study includes only one treatment group where patients undergo this minimally invasive valve replacement procedure. During the study, participants will be monitored for up to five years. Researchers will evaluate survival without all-cause mortality at one year as the primary outcome. Secondary assessments include mortality at multiple time points, rates of severe adverse events, heart function ratings using the NYHA classification, and quality of life measured by the Kansas City Cardiomyopathy score. Safety and performance will be closely followed through scheduled evaluations.

Mi-thos® Transcatheter Mitral Valve Replacement Study